Kornimate/medical-research-clean huggingface dataset:
epigenetic nucleosomes in plasma for pulmonary nodule differentiation

Conditions: Lung Nodule

Summary: we aim to evaluate the diagnostic accuracy of the nu.q blood test for lung cancer in the taiwanese population and compare its diagnostic performance with low-dose computed tomography (ldct) or computed tomography (ct). additionally, we will investigate the potential role of nu.q in lung cancer prevention and its impact on survival outcomes. study method: we plan to collect 20 ml of blood samples from individuals undergoing chest ldct/ct, isolate plasma for nu.q™ analysis, and compare the results with corresponding lung cancer pathology findings. the estimated sample size is 500 participants.

currently, early lung cancer screening primarily relies on low-dose computed tomography (ldct) of the chest. however, blood tests offer a more convenient alternative. despite this, existing blood tests lack sufficient accuracy and sensitivity for lung cancer screening. developing a reliable blood-based screening tool could significantly enhance the detection rate and accuracy of early lung cancer screening. previous studies have shown that nucleosomes undergo variations during early cancer development. the belgian company volition has developed a blood test method based on chemiluminescence immunoassay (chlia) to measure nucleosomes in the blood, branded as nu.q™. preliminary studies have demonstrated that nu.q™ can detect abnormal nucleosome biomarkers associated with early lung cancer. this study, in collaboration with volition, will collect 20 ml of blood samples from individuals undergoing chest ldct. plasma will be isolated and analyzed using nu.q™ at the national taiwan university center for genomics and precision medicine. the test results will be compared with corresponding lung cancer medical records, ldct findings, and pathological diagnoses. the study aims to enroll 500 participants. the objectives of this study are to validate the diagnostic accuracy of the nu.q™ blood test for lung cancer in the taiwanese population, compare its diagnostic performance with ldct, and explore its potential role in lung cancer prevention and improved survival outcomes. this study is conducted as an industry-academic collaboration project with national taiwan university.

Eligibility criteria:
inclusion criteria: * aged 20 or older * underwent a low-dose chest ct scan or a standard chest ct scan, showing lung nodules ≥ 6mm * individuals understand the content of the consent form and are willing to participate in this study. * the lung nodule is assessed by a physician as high-risk, requiring thoracic surgery or biopsy for diagnosis exclusion criteria: * pregnant women * individuals without capacity for consent, unable to understand the content of the consent form, or unwilling to participate in this study * assessed by a physician as unsuitable for thoracic surgery or biopsy for diagnosis

Keywords: liquid biopsy epigenetic
implementation of a trimodal prehabilitation program as a preoperative optimization strategy in cardiac surgery and heart transplant

Conditions: Coronary Artery Disease; Valvular Heart Disease

Summary: pre-habilitation programs that combine physical training, nutritional support and emotional reinforcement have demonstrated efficacy as presurgical optimization strategies in the context of digestive surgery. the experience in patients at risk for cardiac surgery, one of those associated with higher morbidity and mortality, is anecdotal. main objective: to evaluate the feasibility, efficacy and cost-effectiveness of a pre-habilitation program for the improvement of preoperative functional capacity in high-risk and intermediate risk groups for cardiac surgery and its impact on the reduction of postoperative complications (primary endpoint). secondary objectives: (i) in-hospital stay; (ii) symptoms, quality of life, (iii) evaluation of information and communication technologies (ict) as a support for the pre-habilitation, and (iv) design and validation of indicators for a future large-scale implementation of this type of intervention. design: subproject: #1: prospective study of the efficacy of prehabilitation in heart transplant candidates during the study period. the results will be compared with historical records; #2: randomized controlled trial with a 1:1 ratio to assess the efficacy of prehabilitation in patients undergoing elective coronary revascularization or valve replacement surgery. subjects: subproject #1: 40 patients candidates for heart transplantation. subproject #2: 80 patients in the prehabilitation group and 80 controls in which a conventional treatment will be performed. intervention: (i) personalized supervised resistance training, and (ii) program to promote physical activity and healthy lifestyles. the overall duration of the intervention is estimated to be at least 4-6 weeks (variable in each subproject). the support with icts will be a significant aspect of the program in which the adaptation of the personal health folder of catalonia (cat@salutlamevasalut) will be fundamental.


Eligibility criteria:
inclusion criteria: * subproject #1: heart transplant candidates * subproject #2: patients awaiting for coronary artery bypass or valve surgery with an expected waiting time for surgery of 8-12 weeks exclusion criteria: * dynamic left ventricular outflow tract obstruction (\> 40 mmhg) * arrythmia induced by exercise * emergent surgery * unstable cardiac disease * unstable severe co-morbid disease * disabling orthopedic and neuromuscular disease * cognitive impairment * refusal to participate in the study
study to assess effect of cyclosporine on the blood levels of ticagrelor

Conditions: Healthy

Summary: the purpose of this study is to assess the effect of cyclosporine on the blood levels of ticagrelor.

a single-center,open-label,randomized,3-treatment,3-period cross-over study to investigate the potential effect of cyclosporine on the pharmacokinetics, safety, and tolerability of ticagrelor and the effect of ticagrelor on the pharmacokinetics, safety, and tolerability of cyclosporine.

Eligibility criteria:
inclusion criteria: * provision of signed and dated written informed consent prior to any study-specific procedures * healthy male subjects aged 18 to 45 years (inclusive) with suitable veins for cannulation or repeated venipuncture exclusion criteria: * history or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs * a history of hemophilia, von willebrand's disease, lupus anti-coagulant, or other diseases/syndromes that can either alter or increase the propensity for bleeding * a personal history of vascular abnormalities including aneurysms; a personal history of severe hemorrhage, hematemesis, melena, hemoptysis, severe epistaxis, severe thrombocytopenia, intracranial hemorrhage, or rectal bleeding within 1 year

Keywords: phase 1 healthy male volunteers pharmacokinetics cyclosporine ticagrelor bioavailability (plasma auc, cmax, plasma auc0-t, t1/2λz, tmax)
a study to investigate the safety, tolerability, pk, pd, and efficacy of ono-7018 in patients with r/r nhl or cll

Conditions: Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell

Summary: this is a phase 1, open-label, multicenter study. this will be the first-in-human clinical study for ono-7018 and will be conducted in two phases: a dose escalation phase (part 1) and a dose expansion phase (part 2).

ono-7018 is a selective inhibitor of mucosa associated lymphoid tissue protein 1 (malt1) and is expected to exhibit antitumor activity in nhl and cll. the purpose of this study is to determine the mtd and to evaluate the safety, tolerability, pk, pharmacodynamics (biomarkers), and efficacy of ono-7018 in patients with relapsed or refractory nhl or cll.

Eligibility criteria:
inclusion criteria: 1. patient aged ≥ 18 years 2. written informed consent by the patient or the patient's legally authorized representative 3. patient with histologically/cytologically confirmed diagnosis of nhl or cll 4. patient with relapsed or refractory disease who has no available therapeutic options known to provide clinical benefit 5. patient who has measurable disease 6. all acute toxic effects of any prior antitumor therapy, including investigational therapy, resolved to grade ≤ 1 before the start of study therapy 7. eastern cooperative oncology group performance status 0 to 2 8. adequate bone marrow, renal and hepatic functions exclusion criteria: 1. history of lymphoid malignancy other than those allowed per inclusion criteria 2. patient with central nervous system involvement 3. patient with systemic and active infection 4. any serious or uncontrolled medical disorder that may increase the risk associated with study participation or study treatment, or interfere with the interpretation of study results 5. prior treatment with a malt1 inhibitor 6. patient receiving any other investigational drug within 4 weeks prior to study entry 7. patient is unable to swallow tablets 8. patient is found to be otherwise ineligible for the study by the investigator or sub investigator

Keywords: ono-7018, malt1 inhibitor, lymphoma, leukemia
sphere per-af post-approval study

Conditions: Persistent Atrial Fibrillation

Summary: sphere per-af post-approval study is a prospective, multi-center, non-randomized, observational trial. subjects will be treated with the sphere-9™ catheter and affera™ ablation system and followed through 36 months.

the purpose of the study is to evaluate the long-term effectiveness and safety of the sphere-9™ catheter and affera™ ablation system in a post-approval setting for the treatment of drug refractory, recurrent, symptomatic, persistent af (episode duration less than one year).

Eligibility criteria:
inclusion criteria: 1. a diagnosis of recurrent symptomatic persistent af (continuous af sustained longer than 7 days but less than 12 months) 2. refractory (i.e. not effective, not tolerated, or not desired) to at least one class i or iii antiarrhythmic drug (aad) 3. patient is ≥ 18 years of age 4. planned de novo pulmonary vein isolation procedure using commercially available sphere-9™ catheter and affera ablation system 5. patient is willing and able to comply with study requirements and give informed consent exclusion criteria: 1. long-standing persistent af (continuous af sustained \>12 months) 2. prior left atrial catheter or surgical ablation 3. life expectancy \<36 months 4. presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (icm), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) 5. current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by medtronic
sex-specific differences in aaa complexity

Conditions: AAA - Abdominal Aortic Aneurysm

Summary: a retrospective cohort study of computed tomography scans of aaa patients considered for repair, in order to identify sex specific differences in abdominal aortic aneurysm (aaa) metrics and the association between anatomical differences/features of complexity and adverse patient outcome.

a retrospective cohort study of computed tomography scans of aaa patients considered for repair. the study aims to, firstly, identify sex specific differences in abdominal aortic aneurysm (aaa) metrics utilising manual and automated image processing techniques; and secondly, if numbers are sufficient, explore the association between features of aaa complexity and adverse patient outcome.

Eligibility criteria:
inclusion criteria: * all adult patients with aaa receiving assessment +/- primary open or endovascular repair at participating centre from 1/1/2010 to 31/12/2020. * must have aaa \>= 5cm. * must have ct imaging within 1 year of operation or definitive turn down for treatment. exclusion criteria: * insufficient ct imaging quality (\>3mm slices) or lack of ct within 1 year of operation. * insufficient clinical data to establish risk factors or clinical outcomes. * ruptured aneurysm, aorto-iliac occlusive disease, isolated iliac aneurysm, penetrating aortic ulcer, dissection, juxta or supra-renal aneurysm. * secondary repair/not primary treatment decision for aaa repair.
performance and safety of routine cataract surgery with visiol

Conditions: Following Cataract Surgery

Summary: in this clinical investigation, the performance and safety of routine cataract surgery with visiol will be assessed


Eligibility criteria:
inclusion criteria: * male or female aged 18 years and older; * candidate for cataract surgery via phacoemulsification; * ophthalmic surgeon's recommendation to use visiol prior to recruitment; * eligible for the use of visiol as indicated in the instructions for use; * written informed consent. exclusion criteria: * known allergy or hypersensitivity to any of visiol components; * known pregnancy or breast feeding; * participation in any other clinical research study within the last 90 days; * patients with legally restricted autonomy, freedom of decision and action (e.g. those with measure of custody or judicial protection); * incapacity to understand the informed consent and/or to comply with the clinical investigation plan (cip), per investigator's appreciation.
gender differences in parkinsonian patients- a swedish register study

Conditions: Parkinson Disease

Summary: background: the complex impact of gender has been studied in different perspectives of health and disease in the literature. however, few attempts have been made to compile data from systematic disease specific registrations swedish national quality registers play an important role in collecting large amounts of diagnose specific data, symptoms, and treatments. the subset parkinson registry has been in use for more than 20 years and are represented in all counties and hospitals where neurological care is provided in sweden and offer optimal conditions to describe gender specific differences in the use of diagnostic tools, lead times and symptom profiles.

aim: to study differences between gender in diagnostic tools, pharmacological interventions, and self-reported symptoms in parkinson´s disease (pd). methods: data were extracted from the swedish neuro registers, one of the swedish national quality registers. a mix of urban and rural parts of the country were chosen and data were divided by gender. self-reported first experienced pd related symptom was used to define the starting point when processing the data. zero to three years from this point was defined as early symptoms and over three years as late symptoms. conclusion: differences between gender were seen in all chosen aspects, both diagnostically. distinctions were also prominent in reported nonmotorsymptoms (nms) profiles. these findings should be important to take into consideration for patients, professional staff, and caregivers in the daily work with gender mixed pd groups.

Eligibility criteria:
inclusion criteria: * participants registered in the swedish neuro registers. * parkinson´s disease * acceptance of extraction of data exclusion criteria: * non parkinsonian patients * participants in the registries who have not given allowance of extraction of data.

Keywords: nonmotorsymptoms, medication, national registries
study to promote weight loss in primary care practices

Conditions: Obesity

Summary: the purpose of this study is to determine if primary care based, telephone-delivered weight loss interventions are effective.

obesity is related to the rising incidence of type 2 diabetes. cost-effective interventions leading to sustained weight loss are needed to improve the public health and reverse the alarming rise in diabetes, its cardiovascular complications and other obesity-related illnesses. the diabetes prevention program is identified as a model for a successful weight loss intervention. the proposed study is a randomized controlled trial of 2 active telephone-based interventions based on the diabetes prevention model that will be delivered at primary care sites.

Eligibility criteria:
inclusion criteria: * obese * metabolic syndrome * read and write english * planning to stay in treatment with their pcp for the next 3 years * on stable doses of medications for chronic diseases such as hypothyroidism for 3 years exclusion criteria: * unstable health * diabetes mellitus * severe medical comorbidities that might interfere with their ability to participate in intervention such as severe psychiatric disease or significant heart disease.

Keywords: obesity metabolic syndrome weight loss diabetes prevention
study of b013 and nab-paclitaxel for locally advanced or metastatic triple negative breast cancer

Conditions: Triple Negative Breast Cancer (TNBC)

Summary: this phase ii/iii study assessed the efficacy, safety, pharmacokinetics, and immunogenicity of b013 administered with nab-paclitaxel in participants with locally advanced or metastatic triple negative breast cancer (tnbc) who have not received prior systemic therapy for metastatic breast cancer (mbc).


Eligibility criteria:
inclusion criteria: 1. women or men aged 18 -75 years 2. locally advanced or metastatic triple negative breast cancer (tnbc) 3. no prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic tnbc 4. ecog performance status of 0 or 1 5. patient must have measurable or evaluable disease as defined by recist v1.1. measurable lesions will be confirmed by radiographic imaging (ct or mri) exclusion criteria: 1. previous treatment is eligible. 2. spinal cord compression not definitively treated with surgery and/or radiation prior to study entry 3. known central nervous system (cns) disease 4. uncontrolled pleural effusion, pericardial effusion, or ascites patients 5. uncontrolled tumor-related pain prior to study entry 6. the patient has a history of another malignancy within 5 years prior to study entry, except adequately treated non-melanotic skin cancer, carcinoma in situ of the cervix or papillary carcinoma of the thyroid 7. pregnancy or lactation
safety of one dose of meningococcal acwy conjugate vaccine in subjects from 2 months to 55 years of age in the republic of south korea

Conditions: Meningococcal Disease

Summary: a multicenter, single arm, post-marketing surveillance study. this study is a postlicensure requirement of the korea food and drug administration (kfda) to provide continued safety evaluation of menacwy in the korean population from 2 months to 55 years of age, receiving menacwy-crm vaccination according to routine clinical practice and prescribing information.


Eligibility criteria:
inclusion criteria: individuals eligible for enrolment in this study are those: 1. male and female subjects from 2 months to 55 years of the age at the time of visit 1 (including all 55 years old subjects, up to one day before their 56th year birthday), who are scheduled to receive vaccination with menacwy-crm conjugate vaccine, according to the local prescribing information and routine clinical practice; 2. to whom the nature of the study has been described and the subject or subject's parent/legal representative has provided written informed consent; 3. whom the investigator believes that the subject can and will comply with the requirements of the protocol (e.g., completion of the diary card); 4. who are in good health as determined by the outcome of medical history, physical assessment and clinical judgment of the investigator. exclusion criteria: 1. contraindication, special warnings and/or precautions, as evaluated by the investigators, reported in the menacwy-crm conjugate vaccine korean prescribing information. in particular, should not be included in the study a subject who has ever had: * an allergic reaction to the active substances or any of the other ingredients of the study vaccine; an allergic reaction to diphtheria toxoid; * an illness with high fever; however, a mild fever or upper respiratory infection (for example cold) itself is not a reason to delay vaccination. special care should be taken for subjects having haemophilia or any other problem that may stop your blood from clotting properly, such as persons receiving blood thinners (anticoagulants).

Keywords: conjugate vaccine phase iv clinical trial neisseria meningitidis
a study to investigate the safety and efficacy of kqb198 as monotherapy and in combination in participants with advanced solid malignancies

Conditions: Solid Tumor, Adult

Summary: the goal of this clinical trial is to learn if kqb198 works to treat advanced solid tumor cancer in adults. it will also learn about the safety of kqb198. the main questions it aims to answer are: * what is the safe dose of kqb198 by itself or in combination with other anti-cancer drugs? * does kqb198 alone or in combination with other anti-cancer drugs decrease the size of the tumor? * what happens to kqb198 in the body? participants will: * take kqb198 daily, alone or in combination with another anti-cancer drug * visit the clinic about 8 times in the first 8 weeks, and then once every 4 weeks after that


Eligibility criteria:
inclusion criteria: * part 1: histologically confirmed diagnosis of a solid tumor malignancy with any of the following oncogenic mutations: egfr, ras, ptpn11, or sos1 mutations, or inactivating mutations of nf1. * part 1 (osimertinib arm) and part 2 cohort a: histologically confirmed diagnosis of nsclc with activating egfr mutation and progression on osimertinib * part 3 cohort a: histologically confirmed diagnosis of nsclc with exon 20 insertion egfr mutation * unresectable or metastatic disease * no available treatment with curative intent * adequate organ function * measurable disease per recist 1.1. exclusion criteria: * prior therapy with a similar mechanism of action to kqb198 * history of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow * history of interstitial lung disease * cardiac abnormalities
evaluation of energy expenditure, body composition and recovery rates in children with severe acute malnutrition

Conditions: Children; Malnutrition

Summary: this project is being conducted with an aim to find out energy expenditure, body composition and recovery rates in children with severe acute malnutrition (sam) receiving community-based nutritional rehabilitation therapy

objectives 1. to assess energy expenditure and body composition by stable isotope techniques in children with severe acute malnutrition 2. to evaluate the potential usefulness of body composition assessment as a predictor of outcome in children with sam, based on stable isotope technique and multi-frequency bioelectrical impedance analysis (bia) inclusion criteria * parents of children of age 6 months to 3 years * resident of study area exclusion criteria * children with congenital malformations * chronic debilitating illnesses * refusal by parents to enroll in study

Eligibility criteria:
inclusion criteria: * parents of children of age 6 months to 3 years * resident of study area exclusion criteria: * children with congenital malformations * chronic debilitating illnesses * refusal by parents to enroll in study

Keywords: sam rutf bia d2o children with severe malnutrition